Impurity Profiling - Liquid Vial Product

Discussions about methods, troubleshooting and best practices across both pharmaceutical and biopharmaceutical analysis.

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When Carrying out impurity profiling of a new Drug Product vs RLD in the case of a Liquid vial product - would it be expected by the FDA that for this study the vials should be in inverted position or upright position - or maybe both positions?
I would think it would only need to be for the position that is recommended to the customer for storage (upright, I assume), assuming you're testing for formulation impurity and not container impurity (like with leachables analysis).
"Have you tried explaining it to the rubber duck?"
We had over the counter pharmaceuticals and had samples tilted so that the contents would be in contact with both container and closure.
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